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Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Lumiracoxib
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Musculoskeletal pain, cyclooxygenase-2 inhibitors, lumiracoxib, naproxen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria Patients with acute musculoskeletal pain following an uncomplicated soft tissue injury (within the last 72 hours) which is expected to be self-limiting, requiring short-term treatment with a NSAID. Patients' acute musculoskeletal pain at baseline must be ≥ 50 mm on a 0 - 100 mm on a Visual Analogue Scale. Patients may have taken analgesic therapy following injury. However, the baseline pain intensity assessment should be taken: (i) 4 hours after the last dose of ≤ 400 mg ibuprofen, ≤ 1000 mg paracetamol, ≤ 600 mg aspirin or ≤ 2 tablets of other over-the-counter analgesic aspirin-based or paracetamol-based combination medications (ii) or 8 hours after the last dose of > 400 mg ibuprofen or ≤ 50 mg diclofenac Exclusion Criteria Patients whose pain is due to an acute exacerbation of a chronic condition e.g. osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus. Patients who have taken non-steroidal anti-inflammatory drugs in the previous 24 hours (other than aspirin, ibuprofen, diclofenac, as described above). Other protocol-defined inclusion/ exclusion criteria may apply.

Sites / Locations

  • For site information contact, Novartis Pharmaceuticals UK Limited

Outcomes

Primary Outcome Measures

Decrease in sum of pain intensity difference scores over first 5 days of treatment

Secondary Outcome Measures

Decrease in sum of pain intensity difference scores over 7 days of treatment; Improvement in how pts feel about their pain; Comparable perceived pain relief; Comparable treatment satisfaction
Safety and efficacy as compared to naproxen.

Full Information

First Posted
September 9, 2005
Last Updated
October 12, 2006
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00170898
Brief Title
Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain
Official Title
A 7-Day Multicenter Randomized Double-Blind, Double-Dummy Parallel Group Trial to Assess the Safety and Efficacy of 400 mg Lumiracoxib Once Daily Versus 500 mg Naproxen Twice Daily in Patients With Acute Musculoskeletal Pain Due to Uncomplicated Soft Tissue Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This study is designed to develop our understanding of the risk-benefit of using lumiracoxib in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
Musculoskeletal pain, cyclooxygenase-2 inhibitors, lumiracoxib, naproxen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
419 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lumiracoxib
Primary Outcome Measure Information:
Title
Decrease in sum of pain intensity difference scores over first 5 days of treatment
Secondary Outcome Measure Information:
Title
Decrease in sum of pain intensity difference scores over 7 days of treatment; Improvement in how pts feel about their pain; Comparable perceived pain relief; Comparable treatment satisfaction
Title
Safety and efficacy as compared to naproxen.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria Patients with acute musculoskeletal pain following an uncomplicated soft tissue injury (within the last 72 hours) which is expected to be self-limiting, requiring short-term treatment with a NSAID. Patients' acute musculoskeletal pain at baseline must be ≥ 50 mm on a 0 - 100 mm on a Visual Analogue Scale. Patients may have taken analgesic therapy following injury. However, the baseline pain intensity assessment should be taken: (i) 4 hours after the last dose of ≤ 400 mg ibuprofen, ≤ 1000 mg paracetamol, ≤ 600 mg aspirin or ≤ 2 tablets of other over-the-counter analgesic aspirin-based or paracetamol-based combination medications (ii) or 8 hours after the last dose of > 400 mg ibuprofen or ≤ 50 mg diclofenac Exclusion Criteria Patients whose pain is due to an acute exacerbation of a chronic condition e.g. osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus. Patients who have taken non-steroidal anti-inflammatory drugs in the previous 24 hours (other than aspirin, ibuprofen, diclofenac, as described above). Other protocol-defined inclusion/ exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals UK Limited Novartis Pharmaceuticals UK Limited
Organizational Affiliation
Novartis Pharmaceuticals UK Limited
Official's Role
Study Director
Facility Information:
Facility Name
For site information contact, Novartis Pharmaceuticals UK Limited
City
Frimley
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19143855
Citation
Kyle C, Zachariah J, Kinch H, Ellis G, Andrews C, Adekunle F. A randomised, double-blind study comparing lumiracoxib with naproxen for acute musculoskeletal pain. Int J Clin Pract. 2008 Nov;62(11):1684-92. doi: 10.1111/j.1742-1241.2008.01906.x.
Results Reference
derived

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Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain

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